Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-27 @ 2:59 PM
Study NCT ID:
NCT01081769
Status:
COMPLETED
Last Update Posted:
2015-02-18
First Post:
2010-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prevention of Relapse With Injectable Paliperidone Palmitate Versus Oral Antipsychotics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068882', 'term': 'Paliperidone Palmitate'}, {'id': 'D014150', 'term': 'Antipsychotic Agents'}], 'ancestors': [{'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D014149', 'term': 'Tranquilizing Agents'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D011619', 'term': 'Psychotropic Drugs'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'title': 'EMEA Medical Affairs Director Psychiatry', 'organization': 'Janssen-Cilag Germany'}, 'certainAgreement': {'otherDetails': "A copy of the manuscript must be provided to the Sponsor for review at least 60 days prior to submission for publication or presentation.\n\nNo paper that incorporates Confidential Information will be submitted for publication without Sponsor's prior written consent. If requested in writing, such publication will be withheld for up to an additional 60 calendar days. A publication from the individual Study site data will not be published until the combined results have been published.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'from randomization until maximally month 24', 'description': 'Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events', 'eventGroups': [{'id': 'EG000', 'title': 'Paliperidone Palmitate', 'description': '2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter', 'otherNumAtRisk': 376, 'otherNumAffected': 208, 'seriousNumAtRisk': 376, 'seriousNumAffected': 42}, {'id': 'EG001', 'title': 'Oral Antipsychotics', 'description': 'Oral antipsychotics daily treatment according to local label for maximally 24 months', 'otherNumAtRisk': 388, 'otherNumAffected': 208, 'seriousNumAtRisk': 388, 'seriousNumAffected': 48}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 65}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Muscle rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 23}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 39}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 15}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 23}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Amenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 7}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}], 'seriousEvents': [{'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Hepatic echinococciasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Prognathism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Acute psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 22}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Schizophrenia, paranoid type', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Varicocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Relapse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': 'paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'oral antipsychotics daily treatment according to local label for maximally 24 months'}], 'classes': [{'categories': [{'measurements': [{'value': '616', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '603', 'spread': '13.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0191', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'from baseline (Day 1 of core phase) up to maximally 24 months.', 'description': 'Number of days from baseline (day 1 of core phase) to relapse as evaluated according the Csernansky criteria. A patient was considered to have relapsed if they met one or more of the following criteria: (1) psychiatric hospitalization; (2) an increase in the level of psychiatric care and an increase of 25 percent (%) from baseline in the Positive And Negative Syndrome Score (PANSS) total score (or an increase of 10 points if the baseline score was 40 or less); (3) deliberate self-injury; (4) suicidal or homicidal ideation that was clinically significant in the investigator\'s judgment; (5) violent behavior resulting in clinically significant injury to another person or property damage; (6) substantial clinical deterioration, defined as a change score of 6 ("much worse") or 7 ("very much worse") on the Clinical Global Impressions Scale (CGI-C); and/or (7) the required dose of the antipsychotic exceeds the maximum approved dose.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': 'Percentage of Treatment Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': 'paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'oral antipsychotics daily treatment according to local label for maximally 24 months'}], 'classes': [{'categories': [{'measurements': [{'value': '75.6', 'groupId': 'OG000', 'lowerLimit': '70.8', 'upperLimit': '79.8'}, {'value': '69.4', 'groupId': 'OG001', 'lowerLimit': '64.5', 'upperLimit': '73.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from baseline (day 1 of core phase) up to maximally 24 months', 'description': 'The proportion of patients achieving a treatment response, defined as a ≥30% decrease (i.e., improvement) in Positive and Negative Syndrome Scale (PANSS) total score from baseline to endpoint. The PANSS is a 30-item scale (Range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate increased severity of schizophrenia symptoms.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PANSS Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': 'paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'oral antipsychotics daily treatment according to local label for maximally 24 months'}], 'classes': [{'title': 'Baseline score', 'categories': [{'measurements': [{'value': '82.5', 'spread': '12.03', 'groupId': 'OG000'}, {'value': '81.5', 'spread': '11.70', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Day 8', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '5.93', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '7.04', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 1', 'categories': [{'measurements': [{'value': '-9.4', 'spread': '10.91', 'groupId': 'OG000'}, {'value': '-8.8', 'spread': '10.15', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 2', 'categories': [{'measurements': [{'value': '-12.2', 'spread': '12.19', 'groupId': 'OG000'}, {'value': '-12.3', 'spread': '11.34', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 3', 'categories': [{'measurements': [{'value': '-14.5', 'spread': '11.72', 'groupId': 'OG000'}, {'value': '-15.0', 'spread': '11.15', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 4', 'categories': [{'measurements': [{'value': '-16.2', 'spread': '13.03', 'groupId': 'OG000'}, {'value': '-16.8', 'spread': '12.34', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 6', 'categories': [{'measurements': [{'value': '-18.5', 'spread': '13.67', 'groupId': 'OG000'}, {'value': '-18.6', 'spread': '13.09', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 9', 'categories': [{'measurements': [{'value': '-19.5', 'spread': '14.72', 'groupId': 'OG000'}, {'value': '-20.1', 'spread': '14.35', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 12', 'categories': [{'measurements': [{'value': '-21.8', 'spread': '13.32', 'groupId': 'OG000'}, {'value': '-21.2', 'spread': '14.45', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 15', 'categories': [{'measurements': [{'value': '-21.7', 'spread': '14.56', 'groupId': 'OG000'}, {'value': '-21.9', 'spread': '14.18', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 18', 'categories': [{'measurements': [{'value': '-23.5', 'spread': '13.56', 'groupId': 'OG000'}, {'value': '-22.8', 'spread': '14.41', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 21', 'categories': [{'measurements': [{'value': '-24.3', 'spread': '13.60', 'groupId': 'OG000'}, {'value': '-23.7', 'spread': '14.66', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 24', 'categories': [{'measurements': [{'value': '-25.5', 'spread': '14.42', 'groupId': 'OG000'}, {'value': '-24.6', 'spread': '14.16', 'groupId': 'OG001'}]}]}, {'title': 'change at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '-16.6', 'spread': '21.42', 'groupId': 'OG000'}, {'value': '-14.1', 'spread': '21.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, day 8, month 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, 24', 'description': 'Change from baseline in the PANSS: The PANSS is a 30-item scale (Range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PANSS Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': 'paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'oral antipsychotics daily treatment according to local label for maximally 24 months'}], 'classes': [{'title': 'Positive Subscale; Baseline score', 'categories': [{'measurements': [{'value': '18.4', 'spread': '3.97', 'groupId': 'OG000'}, {'value': '18.3', 'spread': '4.01', 'groupId': 'OG001'}]}]}, {'title': 'Positive Subscale; change at Day 8', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.36', 'groupId': 'OG001'}]}]}, {'title': 'Positive Subscale; change at Month 12', 'categories': [{'measurements': [{'value': '-6.3', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '4.35', 'groupId': 'OG001'}]}]}, {'title': 'Positive Subscale; change at Month 24', 'categories': [{'measurements': [{'value': '-6.8', 'spread': '4.39', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '4.48', 'groupId': 'OG001'}]}]}, {'title': 'Positive Subscale; change at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '-4.4', 'spread': '6.61', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '6.72', 'groupId': 'OG001'}]}]}, {'title': 'Negative Subscale; Baseline score', 'categories': [{'measurements': [{'value': '22.6', 'spread': '4.55', 'groupId': 'OG000'}, {'value': '22.3', 'spread': '4.58', 'groupId': 'OG001'}]}]}, {'title': 'Negative Subscale; change at Day 8', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '2.10', 'groupId': 'OG001'}]}]}, {'title': 'Negative Subscale; change at Month 12', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '4.69', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '4.80', 'groupId': 'OG001'}]}]}, {'title': 'Negative Subscale; change at Month 24', 'categories': [{'measurements': [{'value': '-6.2', 'spread': '5.19', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '4.74', 'groupId': 'OG001'}]}]}, {'title': 'Negative Subscale; change at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '6.13', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '5.79', 'groupId': 'OG001'}]}]}, {'title': 'General Psychopathology; Baseline score', 'categories': [{'measurements': [{'value': '41.4', 'spread': '6.73', 'groupId': 'OG000'}, {'value': '40.8', 'spread': '6.59', 'groupId': 'OG001'}]}]}, {'title': 'General Psychopathology; change at Day 8', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '3.58', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '4.01', 'groupId': 'OG001'}]}]}, {'title': 'General Psychopathology; change at Month 12', 'categories': [{'measurements': [{'value': '-10.7', 'spread': '7.19', 'groupId': 'OG000'}, {'value': '-10.3', 'spread': '7.64', 'groupId': 'OG001'}]}]}, {'title': 'General Psychopathology; change at Month 24', 'categories': [{'measurements': [{'value': '-12.5', 'spread': '7.63', 'groupId': 'OG000'}, {'value': '-12.0', 'spread': '7.82', 'groupId': 'OG001'}]}]}, {'title': 'General Psychopathology; change at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '-8.1', 'spread': '10.96', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '11.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (day 1 of core phase), day 8, month 12, 24', 'description': 'Change from baseline in positive symptom, negative symptom and general psychopathology subscales of the PANSS scale. The PANSS scale is designed to assess symptoms of schizophrenia by means of the 30-items. The PANSS scale provides subscores for 3 subscales, that is, the positive symptoms subscale (7 items, range 7-49), the negative symptoms subscale (7 items, range 7-49), and the general psychopathology subscale (16 items, range 16-112). Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). Higher scores indicate higher severity of schizophrenia symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PANSS Marder Factor Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': 'paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'oral antipsychotics daily treatment according to local label for maximally 24 months'}], 'classes': [{'title': 'Positive Symptoms Factor Score; Baseline score', 'categories': [{'measurements': [{'value': '22.9', 'spread': '4.26', 'groupId': 'OG000'}, {'value': '22.5', 'spread': '4.39', 'groupId': 'OG001'}]}]}, {'title': 'Positive Symptoms Factor Score; change at Day 8', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.50', 'groupId': 'OG001'}]}]}, {'title': 'Positive Symptoms Factor Score; change at Month 12', 'categories': [{'measurements': [{'value': '-6.9', 'spread': '4.31', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '4.76', 'groupId': 'OG001'}]}]}, {'title': 'Positive Symptoms Factor Score; change at Month 24', 'categories': [{'measurements': [{'value': '-7.6', 'spread': '4.48', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '4.95', 'groupId': 'OG001'}]}]}, {'title': 'Positive Symptoms Factor Score; change at Endpoint', 'categories': [{'measurements': [{'value': '-5.0', 'spread': '6.73', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '6.80', 'groupId': 'OG001'}]}]}, {'title': 'Negative Symptoms Factor Score; Baseline score', 'categories': [{'measurements': [{'value': '22.0', 'spread': '4.65', 'groupId': 'OG000'}, {'value': '21.5', 'spread': '4.95', 'groupId': 'OG001'}]}]}, {'title': 'Negative Symptoms Factor Score; change at Day 8', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': 'Negative Symptoms Factor Score; change at Month 12', 'categories': [{'measurements': [{'value': '-5.1', 'spread': '4.73', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '4.88', 'groupId': 'OG001'}]}]}, {'title': 'Negative Symptoms Factor Score; change at Month 24', 'categories': [{'measurements': [{'value': '-6.5', 'spread': '5.16', 'groupId': 'OG000'}, {'value': '-6.1', 'spread': '5.05', 'groupId': 'OG001'}]}]}, {'title': 'Negative Symptoms Factor Score; change at Endpoint', 'categories': [{'measurements': [{'value': '-4.3', 'spread': '6.26', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '6.08', 'groupId': 'OG001'}]}]}, {'title': 'Disorganized Thoughts Factor; Baseline score', 'categories': [{'measurements': [{'value': '19.5', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '3.41', 'groupId': 'OG001'}]}]}, {'title': 'Disorganized Thoughts Factor; change at Day 8', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '2.06', 'groupId': 'OG001'}]}]}, {'title': 'Disorganized Thoughts Factor; change at Month 12', 'categories': [{'measurements': [{'value': '-4.6', 'spread': '3.42', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '3.78', 'groupId': 'OG001'}]}]}, {'title': 'Disorganized Thoughts Factor; change at Month 24', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '3.90', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '3.82', 'groupId': 'OG001'}]}]}, {'title': 'Disorganized Thoughts Factor; change at Endpoint', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '5.03', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '5.16', 'groupId': 'OG001'}]}]}, {'title': 'Uncontrolled Hostility/Excitement; Baseline score', 'categories': [{'measurements': [{'value': '8.4', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '2.64', 'groupId': 'OG001'}]}]}, {'title': 'Uncontrolled Hostility/Excitement; change at Day 8', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.47', 'groupId': 'OG001'}]}]}, {'title': 'Uncontrolled Hostility/Excitement; change Month 12', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '2.62', 'groupId': 'OG001'}]}]}, {'title': 'Uncontrolled Hostility/Excitement; change Month 24', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.73', 'groupId': 'OG001'}]}]}, {'title': 'Uncontrolled Hostility/Excitement; change Endpoint', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '3.82', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '3.87', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/Depression Factor; Baseline score', 'categories': [{'measurements': [{'value': '9.7', 'spread': '2.74', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '2.85', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/Depression Factor; change at Day 8', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.72', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/Depression Factor; change at Month 12', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '2.56', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/Depression Factor; change at Month 24', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '2.90', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '2.78', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/Depression Factor; change at Endpoint', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '3.51', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '3.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (day 1 of core phase), day 8, month 12 and 24', 'description': 'Change from baseline in schizophrenia symptoms were assessed through the following PANSS factor scores as described by Marder: (1) positive symptoms (range 8-56): sum of delusions, hallucinatory behavior, grandiosity, suspiciousness, stereotyped thinking, somatic concern, unusual thought content, lack of judgment and insight; (2) negative symptoms (range 7-49): sum of blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity, motor retardation, and active social avoidance; (3) disorganized thoughts (range 7-49): sum of conceptual disorganization, difficulty in abstract thinking, mannerisms and posturing, disorientation, poor attention, disturbance of volition, and preoccupation; (4) uncontrolled hostility/excitement (range 4-28): sum of excitement, hostility, uncooperativeness and poor impulse control; (5) anxiety/depression (range 4-28): sum of anxiety, guilt feelings, tension, and depression. Higher scores indicate higher severity of symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression Severity (CGI-S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': 'paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'oral antipsychotics daily treatment according to local label for maximally 24 months'}], 'classes': [{'title': 'Baseline score', 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Day 8', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 1', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 2', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 3', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 4', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 6', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 9', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 12', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 15', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 18', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 21', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 24', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (day 1 of core phase), day 8, month 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, 24', 'description': 'The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global clinical assessment that measures the clinician\'s impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate higher impression of illness severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression-Change (CGI-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': 'paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'oral antipsychotics daily treatment according to local label for maximally 24 months'}], 'classes': [{'title': 'Month 24; Very Much Improved', 'categories': [{'measurements': [{'value': '22.9', 'spread': '22.9', 'groupId': 'OG000'}, {'value': '21.7', 'spread': '21.7', 'groupId': 'OG001'}]}]}, {'title': 'Month 24; Much Improved', 'categories': [{'measurements': [{'value': '52.9', 'spread': '52.9', 'groupId': 'OG000'}, {'value': '47.8', 'spread': '47.8', 'groupId': 'OG001'}]}]}, {'title': 'Month 24; Minimally Improved', 'categories': [{'measurements': [{'value': '17.0', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '20.8', 'spread': '20.8', 'groupId': 'OG001'}]}]}, {'title': 'Month 24; No change', 'categories': [{'measurements': [{'value': '6.7', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'Month 24; Minimally Worse', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 24; Much Worse', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 24; Very Much Worse', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint; Very Much Improved', 'categories': [{'measurements': [{'value': '17.1', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '14.2', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint; Much Improved', 'categories': [{'measurements': [{'value': '40.6', 'spread': '40.6', 'groupId': 'OG000'}, {'value': '35.8', 'spread': '35.8', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint; Minimally Improved', 'categories': [{'measurements': [{'value': '17.4', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '21.9', 'spread': '21.9', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint; No change', 'categories': [{'measurements': [{'value': '10.6', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '10.8', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint; Minimally Worse', 'categories': [{'measurements': [{'value': '5.1', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint; Much Worse', 'categories': [{'measurements': [{'value': '9.1', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '10.6', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint; Very Much Worse', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 24 and endpoint', 'description': "The Clinical Global Impression-Change (CGI-C) rating scale is used to rate the change in severity of the patient's illness compared to baseline (day 1 of core phase) on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Personal and Social Performance (PSP) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': 'paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'oral antipsychotics daily treatment according to local label for maximally 24 months'}], 'classes': [{'title': 'Baseline score', 'categories': [{'measurements': [{'value': '55.3', 'spread': '11.31', 'groupId': 'OG000'}, {'value': '55.3', 'spread': '11.07', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 1', 'categories': [{'measurements': [{'value': '4.9', 'spread': '7.78', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '7.65', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 3', 'categories': [{'measurements': [{'value': '7.6', 'spread': '8.91', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '9.02', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 6', 'categories': [{'measurements': [{'value': '9.9', 'spread': '10.08', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '10.32', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 9', 'categories': [{'measurements': [{'value': '11.4', 'spread': '11.28', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '11.03', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 12', 'categories': [{'measurements': [{'value': '12.7', 'spread': '10.78', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '11.27', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 15', 'categories': [{'measurements': [{'value': '12.9', 'spread': '11.05', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '10.82', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 18', 'categories': [{'measurements': [{'value': '14.0', 'spread': '11.44', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '11.44', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 21', 'categories': [{'measurements': [{'value': '14.7', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '11.69', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 24', 'categories': [{'measurements': [{'value': '15.2', 'spread': '12.72', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '11.72', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '9.8', 'spread': '15.41', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '14.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (day 1 of core phase), month 1, 3, 6, 9, 12, 15, 18, 21 and 24', 'description': "The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short Form-36 Health Survey (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': 'paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'oral antipsychotics daily treatment according to local label for maximally 24 months'}], 'classes': [{'title': 'Physical Component, Baseline score', 'categories': [{'measurements': [{'value': '50.3', 'spread': '8.04', 'groupId': 'OG000'}, {'value': '50.6', 'spread': '7.83', 'groupId': 'OG001'}]}]}, {'title': 'Physical Component, change at Month 6', 'categories': [{'measurements': [{'value': '1.2', 'spread': '6.92', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '6.52', 'groupId': 'OG001'}]}]}, {'title': 'Physical Component, change at Month 12', 'categories': [{'measurements': [{'value': '1.6', 'spread': '7.62', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '7.08', 'groupId': 'OG001'}]}]}, {'title': 'Physical Component, change at Month 24', 'categories': [{'measurements': [{'value': '2.2', 'spread': '8.40', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '6.74', 'groupId': 'OG001'}]}]}, {'title': 'Physical Component, change at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '8.52', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '7.40', 'groupId': 'OG001'}]}]}, {'title': 'Mental Component, Baseline score', 'categories': [{'measurements': [{'value': '32.1', 'spread': '12.62', 'groupId': 'OG000'}, {'value': '31.4', 'spread': '12.92', 'groupId': 'OG001'}]}]}, {'title': 'Mental Component, change at Month 6', 'categories': [{'measurements': [{'value': '8.2', 'spread': '11.58', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '12.43', 'groupId': 'OG001'}]}]}, {'title': 'Mental Component, change at Month 12', 'categories': [{'measurements': [{'value': '10.5', 'spread': '11.75', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '12.77', 'groupId': 'OG001'}]}]}, {'title': 'Mental Component, change at Month 24', 'categories': [{'measurements': [{'value': '12.0', 'spread': '13.34', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '12.83', 'groupId': 'OG001'}]}]}, {'title': 'Mental Component, change at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '9.0', 'spread': '14.99', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '14.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (day 1 of core phase), month 6, 12 and 24', 'description': 'The Short Form-36 Health Survey (SF-36) is a measure of Participant-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Two summary scale scores are computed based on weighted combinations of the 8 subscale scores: the Physical Component Summary and the Mental Component Summary. Each summary scale score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) VAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': 'paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'oral antipsychotics daily treatment according to local label for maximally 24 months'}], 'classes': [{'title': 'Baseline score', 'categories': [{'measurements': [{'value': '57.5', 'spread': '20.94', 'groupId': 'OG000'}, {'value': '57.6', 'spread': '20.41', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 6', 'categories': [{'measurements': [{'value': '10.6', 'spread': '17.31', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '17.00', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 12', 'categories': [{'measurements': [{'value': '15.0', 'spread': '17.38', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '18.32', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 24', 'categories': [{'measurements': [{'value': '17.9', 'spread': '19.48', 'groupId': 'OG000'}, {'value': '18.6', 'spread': '17.36', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '13.0', 'spread': '22.87', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '21.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (day 1 of core phase), month 6, 12 and 24', 'description': "The EQ-5D VAS records the respondent's self-rated health on a vertical, visual analog scale, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual respondent.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': 'paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'oral antipsychotics daily treatment according to local label for maximally 24 months'}], 'classes': [{'title': 'Baseline score', 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.173', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.181', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 6', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.181', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.157', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 12', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.185', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.179', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 24', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.201', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.161', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.224', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.192', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (day 1 of core phase), month 6, 12 and 24', 'description': 'The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead. A higher score indicates an improvement in health in the Health Status Index.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Subjective Well-Being Under Neuroleptics-Short Form (SWN-S) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': 'paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'oral antipsychotics daily treatment according to local label for maximally 24 months'}], 'classes': [{'title': 'Baseline score', 'categories': [{'measurements': [{'value': '76.5', 'spread': '17.02', 'groupId': 'OG000'}, {'value': '76.7', 'spread': '17.07', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 6', 'categories': [{'measurements': [{'value': '8.4', 'spread': '14.06', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '14.40', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 12', 'categories': [{'measurements': [{'value': '11.4', 'spread': '15.81', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '17.02', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Month 24', 'categories': [{'measurements': [{'value': '13.4', 'spread': '18.14', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '15.76', 'groupId': 'OG001'}]}]}, {'title': 'change from baseline at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '9.7', 'spread': '19.17', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '17.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (day 1 of core phase), month 6, 12 and 24', 'description': 'The SWN-S is a patient self-rated scale developed to measure the subjective well-being for the previous 7 days of a patient under neuroleptic treatment. The SWN-S consists of 20 items (each item is rated from 1=not at all to 6=very much). The total score ranges from 20 to 120 with higher score indicating greater subjective well-being.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Patient's Treatment Satisfaction", 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': 'paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'oral antipsychotics daily treatment according to local label for maximally 24 months'}], 'classes': [{'title': 'Effectiveness; Baseline score', 'categories': [{'measurements': [{'value': '61.9', 'spread': '16.97', 'groupId': 'OG000'}, {'value': '59.5', 'spread': '16.82', 'groupId': 'OG001'}]}]}, {'title': 'Effectiveness; change at Month 12', 'categories': [{'measurements': [{'value': '6.7', 'spread': '22.72', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '21.99', 'groupId': 'OG001'}]}]}, {'title': 'Effectiveness; change at Month 24', 'categories': [{'measurements': [{'value': '8.5', 'spread': '21.75', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '20.69', 'groupId': 'OG001'}]}]}, {'title': 'Effectiveness; change at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '23.47', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '25.31', 'groupId': 'OG001'}]}]}, {'title': 'Side-effects; Baseline score', 'categories': [{'measurements': [{'value': '91.3', 'spread': '19.74', 'groupId': 'OG000'}, {'value': '87.3', 'spread': '23.41', 'groupId': 'OG001'}]}]}, {'title': 'Side-effects; change at Month 12', 'categories': [{'measurements': [{'value': '2.1', 'spread': '22.71', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '25.66', 'groupId': 'OG001'}]}]}, {'title': 'Side-effects; change at Month 24', 'categories': [{'measurements': [{'value': '2.8', 'spread': '20.93', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '23.96', 'groupId': 'OG001'}]}]}, {'title': 'Side-effects; change at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '25.59', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '28.24', 'groupId': 'OG001'}]}]}, {'title': 'Convenience; Baseline score', 'categories': [{'measurements': [{'value': '67.1', 'spread': '16.66', 'groupId': 'OG000'}, {'value': '68.4', 'spread': '16.45', 'groupId': 'OG001'}]}]}, {'title': 'Convenience; change at Month 12', 'categories': [{'measurements': [{'value': '8.4', 'spread': '19.10', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '17.79', 'groupId': 'OG001'}]}]}, {'title': 'Convenience; change at Month 24', 'categories': [{'measurements': [{'value': '10.4', 'spread': '20.49', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '17.69', 'groupId': 'OG001'}]}]}, {'title': 'Convenience; change at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '7.4', 'spread': '21.24', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '21.68', 'groupId': 'OG001'}]}]}, {'title': 'Global Satisfaction; Baseline score', 'categories': [{'measurements': [{'value': '64.0', 'spread': '18.13', 'groupId': 'OG000'}, {'value': '62.8', 'spread': '18.31', 'groupId': 'OG001'}]}]}, {'title': 'Global Satisfaction; change at Month 12', 'categories': [{'measurements': [{'value': '8.2', 'spread': '18.89', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '21.18', 'groupId': 'OG001'}]}]}, {'title': 'Global Satisfaction; change at Month 24', 'categories': [{'measurements': [{'value': '8.6', 'spread': '21.06', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '20.39', 'groupId': 'OG001'}]}]}, {'title': 'Global Satisfaction; change at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '25.01', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '26.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (day 1 of core phase), month 12 and 24', 'description': "Patient's satisfaction with medication was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM). The TSQM is divided into 4 subscales (effectiveness, side effects, convenience, and global satisfaction), with the value of each subscale ranging from 0 to 100. Higher scores indicate greater treatment satisfaction.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Physician's Treatment Satisfaction", 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': 'paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'oral antipsychotics daily treatment according to local label for maximally 24 months'}], 'classes': [{'title': 'Efficacy; Baseline score', 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Efficacy; change at Month 12', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Efficacy; change at Month 24', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.98', 'groupId': 'OG001'}]}]}, {'title': 'Efficacy; change at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.43', 'groupId': 'OG001'}]}]}, {'title': 'Safety; Baseline score', 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Safety; change at Month 12', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Safety; change at Month 24', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Safety; change at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': 'Mode of Administration: Baseline score', 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Mode of Administration: change at Month 12', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Mode of Administration: change at Month 24', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Mode of Administration: change at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Overall Satisfaction; Baseline score', 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Overall Satisfaction; change at Month 12', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Overall Satisfaction; change at Month 24', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Overall Satisfaction; change at Endpoint (LOCF)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (day 1 of core phase), month 12 and 24', 'description': "Physician's treatment satisfaction was assessed using the physician's treatment satisfaction scale which is designed to rate 4 aspects of treatment (efficacy, safety, mode of administration, and overall satisfaction), each on a scale ranging from 1 (extremely satisfied) to 7 (extremely dissatisfied).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment'}, {'type': 'PRIMARY', 'title': 'Number of Participants With a Relapse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': 'paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'oral antipsychotics daily treatment according to local label for maximally 24 months'}], 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '300', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0323', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'from baseline (Day 1 of core phase) up to maximally 24 months', 'description': 'Number of participants with a relapse event with relapses evaluated according the Csernansky criteria. A patient was considered to have relapsed if they met one or more of the following criteria: (1) psychiatric hospitalization; (2) an increase in the level of psychiatric care and an increase of 25% from baseline in the PANSS total score (or an increase of 10 points if the baseline score was 40 or less); (3) deliberate self-injury; (4) suicidal or homicidal ideation that was clinically significant in the investigator\'s judgment; (5) violent behavior resulting in clinically significant injury to another person or property damage; (6) substantial clinical deterioration, defined as a change score of 6 ("much worse") or 7 ("very much worse") on the Clinical Global Impressions Scale (CGI-C); and/or (7) the required dose of the antipsychotic exceeds the maximum approved dose.', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paliperidone Palmitate', 'description': '2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'FG001', 'title': 'Oral Antipsychotics', 'description': 'Oral antipsychotics daily treatment according to local label for maximally 24 months'}], 'periods': [{'title': 'Whole Intent-to-Treat', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '376'}, {'groupId': 'FG001', 'numSubjects': '388'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '352'}, {'groupId': 'FG001', 'numSubjects': '363'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Missing Responder Assessment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Stopped; non-responder after 2 weeks', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Deviation; non-responder after 2 weeks', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Responder after 2 weeks, but stopped', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'CORE Intent-To-Treat', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '352'}, {'groupId': 'FG001', 'numSubjects': '363'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '266'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '97'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'Noncompliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Ineligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Visit Schedule Issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Patient Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'After randomization patients enrolled in a 2-week oral treatment phase and were considered part of the whole Intent-to-Treat population (Whole ITT). Five patients did not receive study medication after randomization and were excluded from the whole ITT. Only responders were considered for continuation in the Core treatment phase (Core ITT).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'BG000'}, {'value': '388', 'groupId': 'BG001'}, {'value': '764', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Paliperidone Palmitate', 'description': '2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter'}, {'id': 'BG001', 'title': 'Oral Antipsychotics', 'description': 'Oral antipsychotics daily treatment according to local label for maximally 24 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.5', 'spread': '10.73', 'groupId': 'BG000'}, {'value': '32.4', 'spread': '10', 'groupId': 'BG001'}, {'value': '32.5', 'spread': '10.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '318', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '446', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'AUSTRIA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'BELGIUM', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'BULGARIA', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'CROATIA', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'CZECH REPUBLIC', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'EGYPT', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'ESTONIA', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'FRANCE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'GERMANY', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'HUNGARY', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'ISRAEL', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'ITALY', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'JORDAN', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'KOREA, REPUBLIC OF KOREA', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'LITHUANIA', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'POLAND', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'ROMANIA', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'RUSSIAN FEDERATION', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}, {'title': 'SLOVAKIA', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'SOUTH AFRICA', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'SPAIN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'TAIWAN, PROVINCE OF CHINA', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'TURKEY', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'UKRAINE', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Whole Intent-to-Treat population: All randomized patients who received at least 1 dose of study medication during the screening or treatment phase'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 769}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-17', 'studyFirstSubmitDate': '2010-03-04', 'resultsFirstSubmitDate': '2014-11-17', 'studyFirstSubmitQcDate': '2010-03-04', 'lastUpdatePostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-17', 'studyFirstPostDateStruct': {'date': '2010-03-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Relapse Event', 'timeFrame': 'from baseline (Day 1 of core phase) up to maximally 24 months.', 'description': 'Number of days from baseline (day 1 of core phase) to relapse as evaluated according the Csernansky criteria. A patient was considered to have relapsed if they met one or more of the following criteria: (1) psychiatric hospitalization; (2) an increase in the level of psychiatric care and an increase of 25 percent (%) from baseline in the Positive And Negative Syndrome Score (PANSS) total score (or an increase of 10 points if the baseline score was 40 or less); (3) deliberate self-injury; (4) suicidal or homicidal ideation that was clinically significant in the investigator\'s judgment; (5) violent behavior resulting in clinically significant injury to another person or property damage; (6) substantial clinical deterioration, defined as a change score of 6 ("much worse") or 7 ("very much worse") on the Clinical Global Impressions Scale (CGI-C); and/or (7) the required dose of the antipsychotic exceeds the maximum approved dose.'}, {'measure': 'Number of Participants With a Relapse Event', 'timeFrame': 'from baseline (Day 1 of core phase) up to maximally 24 months', 'description': 'Number of participants with a relapse event with relapses evaluated according the Csernansky criteria. A patient was considered to have relapsed if they met one or more of the following criteria: (1) psychiatric hospitalization; (2) an increase in the level of psychiatric care and an increase of 25% from baseline in the PANSS total score (or an increase of 10 points if the baseline score was 40 or less); (3) deliberate self-injury; (4) suicidal or homicidal ideation that was clinically significant in the investigator\'s judgment; (5) violent behavior resulting in clinically significant injury to another person or property damage; (6) substantial clinical deterioration, defined as a change score of 6 ("much worse") or 7 ("very much worse") on the Clinical Global Impressions Scale (CGI-C); and/or (7) the required dose of the antipsychotic exceeds the maximum approved dose.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Treatment Responders', 'timeFrame': 'from baseline (day 1 of core phase) up to maximally 24 months', 'description': 'The proportion of patients achieving a treatment response, defined as a ≥30% decrease (i.e., improvement) in Positive and Negative Syndrome Scale (PANSS) total score from baseline to endpoint. The PANSS is a 30-item scale (Range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate increased severity of schizophrenia symptoms.'}, {'measure': 'Change From Baseline in PANSS Total Score', 'timeFrame': 'Baseline, day 8, month 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, 24', 'description': 'Change from baseline in the PANSS: The PANSS is a 30-item scale (Range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.'}, {'measure': 'Change From Baseline in PANSS Subscale Score', 'timeFrame': 'Baseline (day 1 of core phase), day 8, month 12, 24', 'description': 'Change from baseline in positive symptom, negative symptom and general psychopathology subscales of the PANSS scale. The PANSS scale is designed to assess symptoms of schizophrenia by means of the 30-items. The PANSS scale provides subscores for 3 subscales, that is, the positive symptoms subscale (7 items, range 7-49), the negative symptoms subscale (7 items, range 7-49), and the general psychopathology subscale (16 items, range 16-112). Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). Higher scores indicate higher severity of schizophrenia symptoms.'}, {'measure': 'Change From Baseline in PANSS Marder Factor Scores', 'timeFrame': 'Baseline (day 1 of core phase), day 8, month 12 and 24', 'description': 'Change from baseline in schizophrenia symptoms were assessed through the following PANSS factor scores as described by Marder: (1) positive symptoms (range 8-56): sum of delusions, hallucinatory behavior, grandiosity, suspiciousness, stereotyped thinking, somatic concern, unusual thought content, lack of judgment and insight; (2) negative symptoms (range 7-49): sum of blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity, motor retardation, and active social avoidance; (3) disorganized thoughts (range 7-49): sum of conceptual disorganization, difficulty in abstract thinking, mannerisms and posturing, disorientation, poor attention, disturbance of volition, and preoccupation; (4) uncontrolled hostility/excitement (range 4-28): sum of excitement, hostility, uncooperativeness and poor impulse control; (5) anxiety/depression (range 4-28): sum of anxiety, guilt feelings, tension, and depression. Higher scores indicate higher severity of symptoms'}, {'measure': 'Change From Baseline in Clinical Global Impression Severity (CGI-S) Score', 'timeFrame': 'Baseline (day 1 of core phase), day 8, month 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, 24', 'description': 'The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global clinical assessment that measures the clinician\'s impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate higher impression of illness severity.'}, {'measure': 'Clinical Global Impression-Change (CGI-C)', 'timeFrame': 'Month 24 and endpoint', 'description': "The Clinical Global Impression-Change (CGI-C) rating scale is used to rate the change in severity of the patient's illness compared to baseline (day 1 of core phase) on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse)."}, {'measure': 'Changes From Baseline in Personal and Social Performance (PSP) Total Score', 'timeFrame': 'baseline (day 1 of core phase), month 1, 3, 6, 9, 12, 15, 18, 21 and 24', 'description': "The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision."}, {'measure': 'Change From Baseline in Short Form-36 Health Survey (SF-36)', 'timeFrame': 'baseline (day 1 of core phase), month 6, 12 and 24', 'description': 'The Short Form-36 Health Survey (SF-36) is a measure of Participant-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Two summary scale scores are computed based on weighted combinations of the 8 subscale scores: the Physical Component Summary and the Mental Component Summary. Each summary scale score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status.'}, {'measure': 'Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) VAS Score', 'timeFrame': 'baseline (day 1 of core phase), month 6, 12 and 24', 'description': "The EQ-5D VAS records the respondent's self-rated health on a vertical, visual analog scale, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual respondent."}, {'measure': 'Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score', 'timeFrame': 'baseline (day 1 of core phase), month 6, 12 and 24', 'description': 'The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead. A higher score indicates an improvement in health in the Health Status Index.'}, {'measure': 'Change From Baseline in Subjective Well-Being Under Neuroleptics-Short Form (SWN-S) Total Score', 'timeFrame': 'baseline (day 1 of core phase), month 6, 12 and 24', 'description': 'The SWN-S is a patient self-rated scale developed to measure the subjective well-being for the previous 7 days of a patient under neuroleptic treatment. The SWN-S consists of 20 items (each item is rated from 1=not at all to 6=very much). The total score ranges from 20 to 120 with higher score indicating greater subjective well-being.'}, {'measure': "Change From Baseline in Patient's Treatment Satisfaction", 'timeFrame': 'baseline (day 1 of core phase), month 12 and 24', 'description': "Patient's satisfaction with medication was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM). The TSQM is divided into 4 subscales (effectiveness, side effects, convenience, and global satisfaction), with the value of each subscale ranging from 0 to 100. Higher scores indicate greater treatment satisfaction."}, {'measure': "Change From Baseline in Physician's Treatment Satisfaction", 'timeFrame': 'baseline (day 1 of core phase), month 12 and 24', 'description': "Physician's treatment satisfaction was assessed using the physician's treatment satisfaction scale which is designed to rate 4 aspects of treatment (efficacy, safety, mode of administration, and overall satisfaction), each on a scale ranging from 1 (extremely satisfied) to 7 (extremely dissatisfied)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'paliperidone palmitate', 'Invega', 'Intramuscular injection', 'Oral antipsychotics', 'Relapse'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '37756123', 'type': 'DERIVED', 'citation': 'Lopena OJ, Alphs LD, Sajatovic M, Turkoz I, Sun L, Johnston KL, Sliwa JK, Najarian DM, Starr HL. Earlier Use of Long-Acting Injectable Paliperidone Palmitate Versus Oral Antipsychotics in Patients With Schizophrenia: An Integrated Patient-Level Post Hoc Analysis. J Clin Psychiatry. 2023 Sep 25;84(6):23m14788. doi: 10.4088/JCP.23m14788.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy (how well the drug works; primarily through the time to relapse) of long-acting injectable paliperidone palmitate compared to treatment as usual with orally administered antipsychotics in monotherapy over 24 months in the treatment of recently diagnosed (1-5 years since diagnosis) schizophrenia.', 'detailedDescription': "This is a randomized (study drug assigned by chance), open-label (both physician and patient know the name of the assigned drug), rater-blinded (the person who assesses the condition of the patient does not know the name of the assigned drug), active-controlled, parallel-group, multicenter, prospective international study of paliperidone palmitate versus treatment as usual with oral antipsychotic agents in monotherapy in the prevention of relapse (return of symptoms). Patients who have been recently diagnosed with schizophrenia (within 5 years) and are suffering from a schizophrenic relapse (return of symptoms of schizophrenia) will be enrolled. This study consists of a 2-week initial acute oral treatment phase, followed by a treatment phase (core phase) until relapse or up to maximally 24 months, whichever comes first. Prior to a 2-week oral treatment phase, patients will be randomly (by chance) assigned in a 1:1 ratio to receive treatment with paliperidone palmitate injection (once-monthly) or oral antipsychotic medication (daily). Patients randomized to paliperidone palmitate will first receive oral paliperidone ER once daily for 2 weeks followed by paliperidone palmitate injections at a dose of 150 mg eq. on Day 1, 100 mg eq. on Day 8 both in the deltoid muscle and 75 mg eq. on Day 38 and doses in a dose range of 25 to 150 mg eq. in either the deltoid or the gluteal muscle thereafter. Patients randomized to oral comparator arm will receive oral antipsychotics (haloperidol, paliperidone ER, risperidone, olanzapine, quetiapine or aripiprazole) as per investigator discretion and prescribed according to the label. Total treatment duration is maximally 24 months. During the 24 month treatment phase, investigators will be allowed to flexibly decrease or increase the dose of paliperidone palmitate with one dose level in the range of 25 to 150 mg eq. or the oral antipsychotic in the respective locally approved dose range, all according to the patient's clinical needs. The primary endpoint of the 24-month treatment phase will be the time to relapse. Safety will be monitored by evaluating Adverse Events (AEs), rating of extrapyramidal symptoms (symptoms like abnormal muscle movements, abnormal movements of the tongue or jaw, slow or sustained muscle contractions, muscle spasms, shaking, abnormal movements of the eyes, involuntary muscle contractions, slow movements, or restlessness), vital signs measurements (including heart rate and blood pressure), body weight and physical examination findings. A urine pregnancy test will be performed in females of childbearing potential. Adverse events (unintended, but not necessarily unexpected, results of therapy that can be unpleasant or dangerous), associated concomitant medications, and symptoms of relapse will be recorded as needed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have been meeting the diagnostic criteria for schizophrenia for 1 to 5 years before screening, and have a history of treatment with antipsychotics\n* Have a history of two or more relapses requiring psychiatric hospitalization in the preceding 24 months, which may include the current acute episode\n* Experiencing at screening an acute schizophrenic episode with a Positive And Negative Syndrome Scale (PANSS) total score at screening between 70 and 120, inclusive\n* Be healthy on the basis of physical examination, medical history and vital signs performed at screening\n* Woman must be postmenopausal (for at least 1 year) or surgically sterile or abstinent or be practicing an effective method of birth control, must agree to continue to use the same method of contraception throughout the study and must have a negative urine pregnancy test at screening\n* be able to fill out questionnaires\n* Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug\n\nExclusion Criteria:\n\n* Patients that have never been treated with antipsychotics before\n* Treatment resistant patient and/or currently (i.within the last 3 months) treated with clozapine\n* Substance dependence within 6 months prior to entry and current intravenous drug use or abuse\n* allergies, hypersensitivity, or intolerance to risperidone or paliperidone or excipients\n* treatment with a long-acting injectable antipsychotic within three injection cycles prior to screening\n* newly started psychotherapy program within the two months preceding the treatment phase baseline\n* evidence of clinically significant hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances in the past 6 months (as determined by medical history, clinical laboratory or ECG results, or physical examination) that would increase the risk associated with taking study medication or would confound the interpretation of the study\n* history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome\n* involuntarily hospitalized patient\n* pregnant or breast-feeding females'}, 'identificationModule': {'nctId': 'NCT01081769', 'acronym': 'PROSIPAL', 'briefTitle': 'Prevention of Relapse With Injectable Paliperidone Palmitate Versus Oral Antipsychotics', 'nctIdAliases': ['NCT01359293'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen-Cilag International NV'}, 'officialTitle': 'A 24-month, Prospective, Randomized, Active-Controlled, Open-Label, Rater-Blinded, Multicenter, International Study of the Prevention of Relapse Comparing Long-Acting Injectable Paliperidone Palmitate to Treatment as Usual With Oral Antipsychotic Monotherapy in Adults With Schizophrenia', 'orgStudyIdInfo': {'id': 'CR015199'}, 'secondaryIdInfos': [{'id': 'R092670SCH3005', 'type': 'OTHER', 'domain': 'Janssen CTMS ID'}, {'id': '2008-002247-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paliperidone Palmitate', 'description': 'paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter', 'interventionNames': ['Drug: paliperidone palmitate injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Antipsychotics', 'description': 'oral antipsychotics daily treatment according to local label for maximally 24 months', 'interventionNames': ['Drug: oral antipsychotics']}], 'interventions': [{'name': 'paliperidone palmitate injection', 'type': 'DRUG', 'description': 'injection with 150 mg equivalent on Day 1, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter', 'armGroupLabels': ['Paliperidone Palmitate']}, {'name': 'oral antipsychotics', 'type': 'DRUG', 'description': 'daily treatment according to local label for maximally 24 months', 'armGroupLabels': ['Oral Antipsychotics']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Bertrix', 'country': 'Belgium', 'geoPoint': {'lat': 49.85596, 'lon': 5.25539}}, {'city': 'Ghent', 'country': 'Belgium', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Liège', 'country': 'Belgium', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Ostend', 'country': 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